Standard operating procedures examples

The form these end products take should be consistent with your company s style for example, if you have specific protocols for project planning or developing Standard Operating Procedures, these will probably apply to comparable tasks within the PSM initiative. 

Higher risk activities will require more forma management systems. For example, a process that uses a highly toxic raw material may require an extensive pre-startup leak check of the process as part of standard operating procedures. 

Note that some organizations may not use the terminology used in this book and may not distinguish between SOPs and WIs. Standard Operating Procedures provide details of how a series of operations are carried out. An example of a SOP would be the detailed instruction for carrying out a particular analytical method. Work Instructions give details of how a specific operation is carried out. What might be classed as a WI is how to operate a particular instrument, how to estimate measurement uncertainty or how to calibrate a piece of equipment. 

In any setup, it is paramount that the electrodes get cleaned regularly. The minimum frequency, e.g., once a week, should be described in the instrument standard operation procedure (SOP), but for some methods or samples more frequent cleaning is necessary. An example is the determination of the enantiomeric purity of adrenaline in local anesthetic solutions. The samples are isotonic and contain high concentrations of local anesthetics (5—20mg/ml). The determination concerns very low concentrations of adrenaline (typically 5 pg/ml of 1-form and only a few percent of that of the d-form) and the samples are therefore injected undiluted. Furthermore, relatively high concentrations of cyclodextrin are present in the BGE. Eong sequences therefore require electrode cleaning for every sequence and this is thus described in the method procedure. ... 

As an example, consider an incident where an employee is exposed while sampling chlorine. One of the root causes is determined to be an inadequate standard operating procedure (SOP) for sampling. A management of change system can provide a mechanism to identify things that... 

Table 3 Examples of in vitro and in vivo bioassays for which standard operating procedures have been developed (Schipper and Stronkhorst 1999) and studied for their applicability in the licensing system for disposal of dredged sediment (own results) or were evaluated in other studies (e.g. ER-CALUX).

Ensuring that suitable processes are employed to guarantee reliable testing, for example the use of standard operating procedures, the conduct of IQC and participation in EQA. 

Another similar example is the reference to Standard Operating Procedures. The testing facility shall have written SOPS that adequately ensure the quality and integrity of the data generated. This is an opportunity for the chemist to ensure that the quality of the science is maintained uniformly and consistently throughout the laboratory, no matter who is doing the... 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

The procedural controls applicable for the preventive maintenance and repair of the hardware provide a mechanism for anticipating problems and, as a consequence, possible loss of data. Modem hardware usually requires minimum maintenance because electronic circuit boards, for example, are usually easily replaced and cleaning may be limited to dust removal. Diagnostic software is usually available from the supplier to check the performance of the computer system and to isolate defective integrated circuits. Maintenance procedures should be included in the organization s standard operating procedures. The availability of spare parts and access to qualified service personnel are important for the smooth operation of the maintenance program. 

Method development includes feasibility and optimization to meet the predefined study requirements. The appropriate standard calibrator range and concentrations of VS and QC (see discussion below) should be established for the dosage form and route of administration. The lessons learned during method development are critical for the development of specific parameters for the performance of the assay. For example, the number of validation batches and acceptance criteria should be described in a validation plan, and the standard operating procedure (SOP) should be written before conducting the pre-study validation. The correct approach should be to develop a valid (acceptable) method, rather than simply... 

EDMSs can be configured in many different ways to support the way documents are managed. Figure 34.2 shows an example life cycle for a document such as a standard operating procedure. 

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